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Phase-III-Studie zum Vergleich von AAA817+ARPI mit dem Standard der Versorgung bei erwachsenen Teilnehmern mit PSMA-positivem MCRPC (AcTFirst)

14. Oktober 2026 aktualisiert von: Novartis Pharmaceuticals

Eine Phase-III-, Open-Label-, Mehrzentrale, randomisierte Studie zum Vergleich von AAA817+ARPI im Vergleich zur Versorgung der Versorgung bei erwachsenen Teilnehmern mit PSMA-positiven metastatischen kastrationsresistenten Prostatakrebs

The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or [177Lu]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is a phase III, open label, multicenter randomized study. The study aims at evaluating the superiority of 225Ac-PSMA-617 combined with androgen receptor pathway inhibitor (ARPI) over a change of ARPI or chemotherapy or [177Lu]Lu-PSMA-617 (AAA617) in prolonging progression free survival (rPFS).

Screening period: At screening, the participants will be assessed for eligibility and will undergo a positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity. Only participants with PSMA positive cancer and confirmed eligibility criteria will be randomized.

Participants randomized to the investigational arms will receive up to 6 doses of AAA817 10 Mbq +/- 10% given intravenously with or without an ARPI (oral enzalutamide or oral abiraterone) per investigator's choice. Treatment with ARPI should continue as per protocol end of treatment criteria.

Participants randomized to SoC will be treated with an ARPI change (oral enzalutamide or oral abiraterone) or taxane-based chemotherapy (docetaxel or cabazitaxel) or [177Lu]Lu-PSMA-617 (AAA617)' per investigator's choice. Treatment with ARPI should continue as per protocol end of treatment criteria. Treatment duration with taxane-based chemotherapy or AAA617will depend on the chosen regimen per the investigator's discretion following local guidelines as per standard of care and product labels and adhere to the protocol end of treatment criteria.

Supportive care will be allowed in both arms at the discretion of the investigator and includes available care for the eligible participant according to best institutional practice for mCRPC treatment, including androgen deprivation therapy (ADT).

Safety will be assessed routinely during the study. Crossover is not allowed among study arms.

The study will be conducted in the USA among other countries globally.

Studientyp

Interventionell

Einschreibung (Geschätzt)

940

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studienorte

  • Australien
      • Adelaide, Australien, 5000
        • Rekrutierung
        • Novartis Investigative Site
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
        • Rekrutierung
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Rekrutierung
        • Novartis Investigative Site
    • Victoria
      • Malvern, Victoria, Australien, 3144
        • Rekrutierung
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
        • Rekrutierung
        • Novartis Investigative Site
  • Brasilien
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 01308-050
        • Rekrutierung
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasilien, 05652-000
        • Rekrutierung
        • Novartis Investigative Site
  • China
      • Beijing, China, 100036
        • Rekrutierung
        • Novartis Investigative Site
      • Beijing, China, 100034
        • Rekrutierung
        • Novartis Investigative Site
      • Guangzhou, China, 510060
        • Rekrutierung
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Rekrutierung
        • Novartis Investigative Site
      • Shanghai, China, 200032
        • Rekrutierung
        • Novartis Investigative Site
      • Shanghai, China, 200001
        • Rekrutierung
        • Novartis Investigative Site
      • Tianjin, China, 300480
        • Rekrutierung
        • Novartis Investigative Site
      • Tianjin, China, 300300
        • Rekrutierung
        • Novartis Investigative Site
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Rekrutierung
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Rekrutierung
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510632
        • Rekrutierung
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Rekrutierung
        • Novartis Investigative Site
      • Wuhan, Hubei, China, 430030
        • Rekrutierung
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Rekrutierung
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210029
        • Rekrutierung
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, China, 110011
        • Rekrutierung
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Rekrutierung
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Rekrutierung
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310007
        • Rekrutierung
        • Novartis Investigative Site
  • Hongkong
      • Hong Kong, Hongkong, 999077
        • Rekrutierung
        • Novartis Investigative Site
  • Indien
    • Haryana
      • Gurgaon, Haryana, Indien, 122002
        • Rekrutierung
        • Novartis Investigative Site
    • Karnataka
      • Bengaluru, Karnataka, Indien, 560066
        • Rekrutierung
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, Indien, 400012
        • Rekrutierung
        • Novartis Investigative Site
  • Japan
      • Chiba, Japan, 2608717
        • Rekrutierung
        • Novartis Investigative Site
      • Fukuoka, Japan, 8128582
        • Rekrutierung
        • Novartis Investigative Site
      • Fukuoka, Japan, 8110213
        • Rekrutierung
        • Novartis Investigative Site
      • Fukuoka, Japan, 8120033
        • Rekrutierung
        • Novartis Investigative Site
      • Fukushima, Japan, 9601295
        • Rekrutierung
        • Novartis Investigative Site
      • Hiroshima, Japan, 7348551
        • Rekrutierung
        • Novartis Investigative Site
      • Kyoto, Japan, 6068507
        • Rekrutierung
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4668560
        • Rekrutierung
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Rekrutierung
        • Novartis Investigative Site
    • Hyōgo
      • Kobe, Hyōgo, Japan, 6500047
        • Rekrutierung
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 6500017
        • Rekrutierung
        • Novartis Investigative Site
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 2478533
        • Rekrutierung
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 2360004
        • Rekrutierung
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 8608556
        • Rekrutierung
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 1040045
        • Rekrutierung
        • Novartis Investigative Site
  • Mexiko
      • Mexico City, Mexiko, 03330
        • Rekrutierung
        • Novartis Investigative Site
  • Singapur
      • Singapore, Singapur, 169608
        • Rekrutierung
        • Novartis Investigative Site
      • Singapore, Singapur, 119074
        • Rekrutierung
        • Novartis Investigative Site
      • Singapore, Singapur, 168583
        • Rekrutierung
        • Novartis Investigative Site
  • Südkorea
      • Seoul, Südkorea, 03080
        • Rekrutierung
        • Novartis Investigative Site
      • Seoul, Südkorea, 05505
        • Rekrutierung
        • Novartis Investigative Site
      • Seoul, Südkorea, 06591
        • Rekrutierung
        • Novartis Investigative Site
      • Seoul, Südkorea, 03722
        • Rekrutierung
        • Novartis Investigative Site
      • Seoul, Südkorea, 06351
        • Rekrutierung
        • Novartis Investigative Site
      • Seoul, Südkorea, 01812
        • Rekrutierung
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Rekrutierung
        • Novartis Investigative Site
      • Taichung, Taiwan, 407219
        • Rekrutierung
        • Novartis Investigative Site
      • Tainan, Taiwan, 704302
        • Rekrutierung
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Rekrutierung
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Rekrutierung
        • Novartis Investigative Site
  • Vereinigte Staaten
    • Alabama
      • Homewood, Alabama, Vereinigte Staaten, 35209
        • Rekrutierung
        • Urology Centers Of Alabama Pc
        • Kontakt:
        • Hauptermittler:
          • Bryant Poole
    • Arizona
      • Tucson, Arizona, Vereinigte Staaten, 85724
        • Rekrutierung
        • University of Arizona
        • Kontakt:
        • Hauptermittler:
          • Bital Savir-Baruch
    • California
      • Orange, California, Vereinigte Staaten, 92868
        • Rekrutierung
        • Univ Cali Irvine ALS Neuromuscular
        • Hauptermittler:
          • Arash Rezazadeh Kalebasty
        • Kontakt:
      • Palo Alto, California, Vereinigte Staaten, 94304
        • Rekrutierung
        • Stanford University Medical Center
        • Hauptermittler:
          • Hong Song
        • Kontakt:
      • Santa Barbara, California, Vereinigte Staaten, 93105
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80218
        • Rekrutierung
        • Rocky Mountain Cancer Centers
        • Hauptermittler:
          • Allen Cohn
        • Kontakt:
    • Florida
      • Fort Myers, Florida, Vereinigte Staaten, 33901
        • Rekrutierung
        • Florida Cancer Specialists
        • Hauptermittler:
          • Bradford Perez
        • Kontakt:
      • Miami, Florida, Vereinigte Staaten, 33173
      • Orlando, Florida, Vereinigte Staaten, 32804
        • Rekrutierung
        • AdventHealth
        • Hauptermittler:
          • Ravi Shridhar
        • Kontakt:
    • Georgia
      • Athens, Georgia, Vereinigte Staaten, 30607
        • Rekrutierung
        • University Cancer and Blood Center LLC
        • Kontakt:
        • Hauptermittler:
          • Gordon Schoenfeld
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60611
        • Rekrutierung
        • Northwestern University
        • Kontakt:
        • Hauptermittler:
          • Maha Hussain
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • Rekrutierung
        • University of Illinois Cancer Center at Chicago
        • Hauptermittler:
          • Natalie Reizine
        • Kontakt:
    • Iowa
      • Iowa City, Iowa, Vereinigte Staaten, 52242
        • Rekrutierung
        • Univ Of Iowa Hospitals And Clinics
        • Kontakt:
        • Hauptermittler:
          • Kristin Plichta
    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160
        • Rekrutierung
        • University of Kansas Hospital
        • Hauptermittler:
          • Xinglei Shen
        • Kontakt:
    • Louisiana
      • Metairie, Louisiana, Vereinigte Staaten, 70006
    • Maine
      • Scarborough, Maine, Vereinigte Staaten, 04074
        • Rekrutierung
        • New England Cancer Specialists
        • Kontakt:
        • Hauptermittler:
          • Christian Anton Thomas
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21287
        • Rekrutierung
        • Johns Hopkins Hospital
        • Hauptermittler:
          • Ana Kiess
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02215
      • Boston, Massachusetts, Vereinigte Staaten, 02215
        • Rekrutierung
        • Beth Israel Deaconess Med Center
        • Hauptermittler:
          • Glenn Bubley
        • Kontakt:
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48201
        • Rekrutierung
        • Karmanos Cancer Institute
        • Kontakt:
        • Hauptermittler:
          • Nitin Vaishampayan
    • Missouri
      • St Louis, Missouri, Vereinigte Staaten, 63110
        • Rekrutierung
        • Wash U School of Medicine
        • Hauptermittler:
          • Jeff Michalski
        • Kontakt:
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68154
    • New Jersey
      • East Brunswick, New Jersey, Vereinigte Staaten, 08816
      • Voorhees Township, New Jersey, Vereinigte Staaten, 08043
        • Rekrutierung
        • New Jersey Urology LLC
        • Kontakt:
        • Hauptermittler:
          • Gordon Brown
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87109
        • Rekrutierung
        • New Mexico Oncology Hematology
        • Kontakt:
        • Hauptermittler:
          • Gregg Franklin
    • New York
      • Cooperstown, New York, Vereinigte Staaten, 13326
        • Rekrutierung
        • Bassett Medical Center
        • Kontakt:
        • Hauptermittler:
          • Timothy Korytko
      • New York, New York, Vereinigte Staaten, 10021
        • Rekrutierung
        • Weill Cornell Medicine NY-Presb
        • Hauptermittler:
          • Scott Tagawa
        • Kontakt:
      • Rochester, New York, Vereinigte Staaten, 14642
      • Syracuse, New York, Vereinigte Staaten, 13210
        • Rekrutierung
        • Associated Med Professionals of NY
        • Hauptermittler:
          • Steven Finkelstein
        • Kontakt:
      • The Bronx, New York, Vereinigte Staaten, 10461
        • Rekrutierung
        • Montefiore Medical Center
        • Hauptermittler:
          • Benjamin A Gartrell
        • Kontakt:
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45212
        • Rekrutierung
        • Urology Group - Solaris Network
        • Kontakt:
        • Hauptermittler:
          • Marc Pliskin
      • Gahanna, Ohio, Vereinigte Staaten, 43230
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Rekrutierung
        • MUSC Hollings Cancer Center
        • Hauptermittler:
          • Kevin Becker
        • Kontakt:
      • Myrtle Beach, South Carolina, Vereinigte Staaten, 29572
        • Rekrutierung
        • Carolina Urologic Research Center
        • Hauptermittler:
          • Neal D Shore
        • Kontakt:
    • Tennessee
      • Chattanooga, Tennessee, Vereinigte Staaten, 37404
        • Rekrutierung
        • Tennessee Oncology PLLC
        • Hauptermittler:
          • Katy Beckermann
        • Kontakt:
    • Texas
      • Lakeway, Texas, Vereinigte Staaten, 78738
      • San Antonio, Texas, Vereinigte Staaten, 78229
      • The Woodlands, Texas, Vereinigte Staaten, 77384
        • Rekrutierung
        • Woodlands Cancer Institute American Oncology Partners
        • Kontakt:
        • Hauptermittler:
          • Jason Berilgen
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98122-4379
        • Rekrutierung
        • Swedish Medical Center
        • Hauptermittler:
          • Song Zhao
        • Kontakt:
      • Tacoma, Washington, Vereinigte Staaten, 98405
        • Rekrutierung
        • Northwest Medical Specialties
        • Hauptermittler:
          • Li Zhang
        • Kontakt:
    • West Virginia
      • Morgantown, West Virginia, Vereinigte Staaten, 26506
        • Rekrutierung
        • West Virginia University Hospital
        • Kontakt:
        • Hauptermittler:
          • Raheel Siddiqui
    • Wisconsin
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53226
        • Rekrutierung
        • Medical College of Wisconsin
        • Hauptermittler:
          • Deepak Kilari
        • Kontakt:
  • Vereinigtes Königreich
      • London, Vereinigtes Königreich, EC1A 7BE
        • Rekrutierung
        • Novartis Investigative Site
    • Oxfordshire
      • Oxford, Oxfordshire, Vereinigtes Königreich, OX4 6LB
        • Rekrutierung
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, Vereinigtes Königreich, SM2 5PT
        • Rekrutierung
        • Novartis Investigative Site
      • Windsor, Surrey, Vereinigtes Königreich, SL4 3HD
        • Rekrutierung
        • Novartis Investigative Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 100 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

Key Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.

  • Participants must be adults ≥ 18 years of age.

  • Participants must have an ECOG performance status of 0 to 2.

  • Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.

  • Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.

  • Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).

  • Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.

  • Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).

    • Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.

Key Exclusion Criteria:

  • Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)

  • Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).

    • Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.

Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.

Other protocol-defined inclusion/exclusion criteria may apply.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)

Participants will receive AAA817 infusion directly into a vein with ARPIs.
Arzneimittel: AAA817

AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy.

Andere Namen:
  • [225Ac]Ac-PSMA-617
Arzneimittel: ARPI

Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone.

Andere Namen:
  • Enzalutamid oder Abirateron
Experimental: Investigational Arm: AAA817

Participants will receive AAA817 infusion directly into a vein.
Arzneimittel: AAA817

AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy.

Andere Namen:
  • [225Ac]Ac-PSMA-617
Aktiver Komparator: Control arm: Investigator's choice of SoC (ARPI or chemotherapy or AAA617)

Participants will receive standard treatment as decided by the trial doctor either as a taxane-based chemotherapy infusion directly into a vein or ARPI change either as capsules or tablets or AAA617 monotherapy infusion directly into a vein.
Arzneimittel: ARPI

Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone.

Andere Namen:
  • Enzalutamid oder Abirateron
Arzneimittel: Standard of Care

Standard treatment includes approved treatment for mCRPC. In this trial, the trial doctor will decide which available treatment participants will receive. The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel or [177Lu]Lu-PSMA-617 (AAA617).

Andere Namen:
  • Arpi Enzalutamid
  • Arpi Abiraterone
  • Chemotherapie auf Taxanbasis von Docetaxel
  • Chemotherapie auf Taxanbasis von Cabazitaxel
  • [177Lu]Lu-PSMA-617 (AAA617)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Radiographic Progression Free Survival (rPFS)
Zeitfenster: From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic disease progression or death due to any cause.
From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS) (Key Secondary Endpoint)
Zeitfenster: From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.

Time to death due to any cause.
From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.
Radiographic Progression Free Survival by by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 (Key Secondary)
Zeitfenster: From date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic disease progression, using by blinded independent central review (BICR) using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria or death due to any cause.
From date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Overall Survival in participants with PSMA-positive mCRPC treated with another ARPI. (Key Secondary)
Zeitfenster: From the date of randomization to the date of death due to any cause.

Time to death due to any cause.
From the date of randomization to the date of death due to any cause.
rPFS in participants treated with AAA817
Zeitfenster: From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

rPFS time to the date of first documented radiographic disease progression or death due to any cause, whichever occurs first.
From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Progression Free Survival (PFS)
Zeitfenster: From date of randomization to the first documented progression by investigator's assessment or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to first documented progression or death due to any cause.
From date of randomization to the first documented progression by investigator's assessment or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Progression Free Survival (PFS2)
Zeitfenster: From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approximately 40.0 months.

Time to first documented progression on next line of antineoplastic therapy or death from any cause.
From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to approximately 40.0 months.
Overall Response Rate (ORR)
Zeitfenster: From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

The proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) in soft tissue.
From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Disease Control Rate (DCR)
Zeitfenster: From the date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

The proportion of participants with BOR of confirmed CR, PR, stable disease (SD) or non-CR/non-progressive disease (PD) in soft tissue.
From the date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Duration of Response (DoR)
Zeitfenster: From the date of first documented response (CR or PR) for confirmed responders and the date of first documented radiographic progression in soft tissue or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time between the date of first documented response and the date of first documented radiographic progression or death due to any cause.
From the date of first documented response (CR or PR) for confirmed responders and the date of first documented radiographic progression in soft tissue or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Time to first radiographic soft tissue progression (TTSTP)
Zeitfenster: From the date of randomization to the date of radiographic soft tissue progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to radiographic soft tissue progression.
From the date of randomization to the date of radiographic soft tissue progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Time to first symptomatic skeletal event (TTSSE)
Zeitfenster: From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to date of first new symptomatic skeletal event of death due to any cause.
From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Prostate specific antigen response (PSA50 and PSA90)
Zeitfenster: From the date of randomization to the date of safety follow up, assessed up to approximately 40.0 months.

The percentage of participants who achieved ≥ 50% and ≥ 90% decrease from baseline, respectively.
From the date of randomization to the date of safety follow up, assessed up to approximately 40.0 months.
Time-concentration profiles and PK parameters of AAA817
Zeitfenster: From Cycle 1 Day 1 up to approximately cycle 5 days 11 (each cycle is 8 weeks).

Time-concentration profiles and PK parameters of AAA817 (e.g. AUC, Cmax).
From Cycle 1 Day 1 up to approximately cycle 5 days 11 (each cycle is 8 weeks).
Change from baseline on FACT-P Prostate Cancer Subscale (PCS)
Zeitfenster: From randomization to the first occurrence of worsening on the score or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Change from baseline on FACT-P Prostate Cancer Subscale (PCS). FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment.
From randomization to the first occurrence of worsening on the score or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Time to worsening on the Worst Pain
Zeitfenster: From randomization to the first occurrence of worsening from baseline, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Time to worsening on the Worst Pain is defined as the time from randomization to the first occurrence of worsening on the Worst Pain item (BPI-SF) or death due to any cause, whichever occurs first.
From randomization to the first occurrence of worsening from baseline, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Novartis Pharmaceuticals

Ermittler

  • Studienleiter: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2025

Primärer Abschluss (Geschätzt)

29. September 2028

Studienabschluss (Geschätzt)

4. November 2032

Studienanmeldedaten

Zuerst eingereicht

18. Februar 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Februar 2025

Zuerst gepostet (Tatsächlich)

3. März 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CAAA817B12301
  • 2024-512340-32 (Registrierungskennung: EU CTIS)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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